Active — Not RecruitingPhase 1/2

Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis

United States38 participantsStarted 2021-03-16

Plain-language summary

This is a Phase 1/2 study in patients with a Recurrent Respiratory Papillomatosis (RRP) disease burden that requires repeated surgical procedures for management. RRP is a rare disease caused by the human papillomavirus (HPV). Participants with a pathologically confirmed diagnosis of papilloma and a clinical diagnosis of RRP will be screened for this protocol.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

INCLUSION CRITERIA: * Age 18 years and older * Clinical diagnosis of RRP * Histological diagnosis of papilloma confirmed by pathology report from a CLIA-certified (or comparable) laboratory * Presence of laryngotracheal papillomas with or without pulmonary RRP * A history of 3 or more interventions in the last 12 months for control of RRP * Clinical performance status of ECOG of 0-1 * Willing to undergo endoscopic evaluation and operative interventions with biopsies in compliance with this protocol * No systemic therapy for RRP for at least 3 half-lives of the prior drug(s). A 30-day washout is required for systemic bevacizumab treatment * Participants who have received prior immunotherapy for RRP are permitted * Participants must have adequate organ and marrow function as defined below: * Sexually active subjects (men and women) of reproductive potential must agree to use two methods of contraception: one highly effective and one other effective method throughout vaccine treatment and for at least 120 days after vaccine treatment. Highly effective methods are defined as: Intrauterine device (IUD), hormonal (birth control pills, injections, implants), tubal ligation, and partner's vasectomy; other effective methods are defined as a latex condom, diaphragm, and cervical cap. * Seronegative for hepatitis B antigen, positive hepatitis B tests can be further evaluated by confirmatory tests (Hep B DNA quant, HBV viral load), and if confirmatory tests are negative, the pa…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Determine the percentage of subjects with a complete response following treatment with PRGN-2012

Timeframe: 1 year

Determine the incidence of dose limiting toxicities to evaluate safety and identify RP2D of PRGN-2012

Timeframe: 28 days

Trial details

NCT IDNCT04724980

SponsorPrecigen, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-05

View on ClinicalTrials.gov More Recurrent Respiratory Papillomatosis trials